GB 18281.2-2015 Active National standards force_standard

GB 18281.2-2015 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes

GB 18281.2-2015 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes

Publish Date: 2015-12-10 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 18281.2-2015

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2015-12-10

Implement Date: 2017-01-01

Pages: 8 pages

Scope

This part of GB 18281 specifies the special requirements and test methods for test microorganisms, bacterial suspensions, contaminated carriers, and biological indicators to be used in evaluating the performance of sterilizers and sterilization processes. The sterilizer uses pure ethylene oxide or a mixture of ethylene oxide and other diluting gases for sterilization, with a sterilization temperature range of 29 °C to 65 °C.

Development Information

Word Count: 13 Thousand words Pages: 8 pages

Same series standard

GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1:General requirements GB 18281.3-2015 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes GB 18281.4-2015 Sterilization of health care products—Biological indicators—Part 4:Biological indicators for dry heat sterilization processes GB 18281.5-2015 Sterilization of health care products—Biological indicator—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes

Replace the following standards

GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization

Superseded by the following standards

GB/T 18281.2-2024 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes

Referenced Standards

ISO 11138-1:2006 ISO 18472

Adopt standards

ISO 11138-2:2006

Related Standards

GB 18278-2000 Replaced

GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization

Publish Date: 2000-12-13

GB 18281.1-2000 Replaced

GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General

Publish Date: 2000-12-13

GB 18281.2-2000 Replaced

GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization

Publish Date: 2000-12-13

GB 18281.3-2000 Replaced

GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization

Publish Date: 2000-12-13

GB 18282.1-2000 Replaced

GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Publish Date: 2000-12-13

YY/T 0567.2-2005 Replaced

YY/T 0567.2-2005 Aseptic processing of health care products—Part 2:filtration

Publish Date: 2005-04-05